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COMMERCE BUSINESS DAILY ISSUE OF JUNE 16,1997 PSA#1867USDA, Food Safety and Inspection Service, ASD, PCS, Room 2161 South
Building, 1400 Independence Avenue SW, Washington, DC 20250-3700 66 -- RAPID DIAGNOSTIC TEST FOR THE DETECTION OF SALMONELLA SEROTYPES
SOL FSIS-33-W-97 DUE 070397 POC Contact Point, Julie Adams, (202)
720-9891 The Food Safety and Inspection Service (FSIS) is requesting
information on any commercially available and collaboratively studied
rapid diagnostic test designed specifically for the detection of all
viable Salmonella serotypes. This information should include all
package inserts, any publications relative to the product and any peer
reviewed evaluation data. Emphasis should be placed on the use of this
product to analyze meat and poultry products. In order for a product to
be considered for FSIS evaluation, it must meet or exceed the following
performance characteristics: Sensitivity >= 97%; Specificity >= 96%;
False Negative rate <=3%; and False Positive rate <= 4%.
Preference will be given to a 96-well format enzyme-linked
immunosorbent assay (ELISA) test which can be run on automated
equipment. The performance criteria given above must be met by running
the ELISA test on automated equipment. The manufacturer must submit
these performance criteria as part of the supporting material for this
submission. Details of the 96-well automated ELISA equipment currently
used by FSIS will be provided upon request. Preference will be given to
an AOAC collaboratively trialled method approved as an AOAC Official
Method of the AOAC INTERNATIONAL. It should be noted that detection of
salmonellae will subsequently require cultural recovery and
confirmation. In addition to the above test performance criteria
derived on 96-well automated ELISA equipment, manufacturers must fully
answer the following: (1) Elapsed time between start of sample
analysis and generation of test results. (2) Potential biological
hazards created by the test method. (3) Total hands-on technical time
required by the test method. (4) Cost of the test. All submissions must
be sent to the Contracting Office at the above address by July 3, 1997.
Only those submissions sent to the Contracting Office will be accepted.
The Agency will review all submissions and select up to three products
which best meet the criteria described above. FSIS will provide each
of the three offers identical sets of 100 whole chicken carcass rinse
samples for analysis by the rapid diagnostic test method run on
automated ELISA equipment. Offerors will be asked to submit the results
of all sample analyses to FSIS for further consideration. All
information supplied will become the property of FSIS. This information
is for planning purposes only and does not constitute an Invitation for
Bid or a Request for Proposals, nor does it promise that any
procurement will follow. No contract award will be made on the basis of
any information received in response to this notice. THERE IS NO
SOLICITATION DOCUMENT AVAILABLE. (0163) Loren Data Corp. http://www.ld.com (SYN# 0284 19970616\66-0004.SOL)
66 - Instruments and Laboratory Equipment Index Page
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